RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Cytokine Storm, SARS-CoV-2
In brief
The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy respectively. The investigators hypothesize that Doxycycline will will improve survival and reduce morbidity in SARS-CoV-2 infected patients. A secondary aim is to identify genetic variants that predict either an unusually mild disease or an unusually severe disease - knowledge that can be used to design new and precise medications and to be able to predict patients who might get into early trouble and to therefore hospitalize them.
Key facts
- Study ID
- NCT04433078
- Run by
- Temple University
- People needed
- 0
- Starts
- 2020-06-22
- Expected to finish
- 2021-04-13
- Last updated by the study team
- 2021-04-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, not requiring hospitalization
- Age ≥18 years
- Willing to sign the informed consent form
- Willing to take study drug or placebo as directed for 21 days
You may not qualify if…
- Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, requiring hospitalization
- Suspected or confirmed convalescent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), within the prior 4 weeks
- Age <18 years' old
- Inability to take medications orally
- Inability to provide written consent
- Known sensitivity/allergy to doxycycline or tetracyclines
- Current use of doxycycline for another indication
- Pregnancy
- A known diagnosis of myasthenia gravis
- History of Clostridium Difficile infection within past 12 months
- Sun sensitivity
- Individuals using medications which could lower doxycycline levels, including barbiturates, phenytoin, carbamazepine, warfarin
- Individuals using isotretinoin
Where it is running
- Temple University Hospital — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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